MAUDE Adverse Event Report: HILL-ROM, INC. ENVELLA; BED, AIR FLUIDIZED

Catalog Number R321EN0089

Device Problem Leak/Splash (1354)

Patient Problem No Information (3190)

Event Date 10/09/2017

Event Type  malfunction  

Event Description

Fine sand was spilling out of the hill-rom envella bed mattress.

• Brand Name: ENVELLA
• Type of Device: BED, AIR FLUIDIZED
• Manufacturer (Section D): HILL-ROM, INC.; 1069 state route 46 east; batesville IN 47006
• MDR Report Key: 6993472
• MDR Text Key: 90786245
• Report Number: 6993472
• Device Sequence Number: 1
• Product Code: INX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: R321EN0089
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/11/2017
• Event Location: Hospital
• Date Report to Manufacturer: 10/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 94 YR